Aromasin

Treats postmenopausal women with estrogen-receptor positive early breast cancer. NDA 20753, held by Pfizer. Exemestane.

As of Nov 13, 2026, NDA 20753 (Aromasin), held by Pfizer, was first approved by FDA on Oct 21, 1999, with 17 approved supplements and 0 published complete response letters.

First approved: Oct 21, 1999
Review: Standard
Supplements approved: 17
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

EXEMESTANE is an aromatase inhibitor indicated for:

adjuvant treatment of postmenopausal women with estrogen-receptor positive early breast cancer who have received two to three years of tamoxifen and are switched to EXEMESTANE for completion of a total of five consecutive years of adjuvant hormonal therapy.
treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy. 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below

Date	Submission	Status	Documents
Jul 25, 2016	Supplement 18Efficacy (new indication or use) · Standard review	Approved	Label Letter
Oct 5, 2005	Supplement 6Efficacy (new indication or use)	Approved	Letter Label
Oct 21, 1999	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Aromasin25MG · tablet;oral	Exemestane	RxReference drug

All 18 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Dec 16, 2024	Supplement 25Labeling · Standard review	Approved	Letter Label
Nov 17, 2021	Supplement 22Labeling · Standard review	Approved	Letter Label
May 18, 2018	Supplement 20Labeling · Standard review	Approved	Label Letter
Jul 25, 2016	Supplement 18Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jul 28, 2014	Supplement 17Manufacturing · Standard review	Approved	None posted
May 2, 2014	Supplement 16Labeling · Standard review	Approved	Letter Label
May 2, 2014	Supplement 15Labeling · Standard review	Approved	Letter Label
Feb 15, 2013	Supplement 14Labeling · Standard review	Approved	Letter Label
Mar 25, 2011	Supplement 12Labeling	Approved	Letter Label
Mar 25, 2011	Supplement 11Labeling · Standard review	Approved	Label Letter
Mar 25, 2011	Supplement 9Labeling · Standard review	Approved	Label Letter
Dec 24, 2008	Supplement 7Labeling · Standard review	Approved	Patient Information Sheet Letter
Oct 5, 2005	Supplement 6Efficacy (new indication or use)	Approved	Letter Label
Sep 23, 2004	Supplement 5Labeling · Standard review	Approved	Label Letter
Nov 13, 2003	Supplement 3Labeling · Standard review	Approved	Label Letter
Apr 4, 2001	Supplement 2Manufacturing · Standard review	Approved	None posted
Apr 4, 2001	Supplement 1Manufacturing · Standard review	Approved	None posted
Oct 21, 1999	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 20753
Drugs@FDA: Overview at FDA
Company: Pfizer

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters